Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for Patients with Previously Treated Advanced Gastric Cancer

Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for Patients with Previously Treated Advanced Gastric Cancer - Randomized Phase II Study Comparing Dose Escalated Weekly Paclitaxel versus Standard Dose Weekly Paclitaxel for AGC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004055

Enrollment

Registered

2010-08-17

Start date

2010-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Treated Advanced or Recurrent Gastric Cancer

Interventions

Standard Dose Weekly Paclitaxel Dose Escalated Weekly Paclitaxel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically proven gastric adenocarcinoma 2. Objectively or clinically progressed after one or more chemotherapy(including recurrence within 6 months after last adjuvant chemotherapy) 3. Age 20 or older 4. ECOG PS 0-2 5. Having Evaluable disease 6. No history of taxanes chemotherapy 7. Fulfill following laboratory data Leucocyte count 3000/mm3 or more Neutrophil count 1500/mm3 or more Platelet count 10.0x104/mm3 or more Hemoglobin level 8.0 g/dL or more Total Bilirubin 1.5 mg/dL or less AST,ALT 100IU/L or less (200IU/L if with liver metastases) Creatinine <2.0mg/dl 8. Life expectancy 8 weeks or more 9. Written informed consent from patient

Exclusion criteria

Exclusion criteria: 1. Alcohol intolerance 2. Symptomatic brain metastasis 3. Paralytic or mechanical bowel obstruction 4. Watery diarrhea 5. Uncontrolled ascites or pleural effusions 6. Confirmed or suspected infection 7. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysematous) 8. Severe comorbidities (uncontrollable diabetes, heart failure with NYHA III or IV, renal failure, liver failure) 9. Pregnant woman, lactating woman 10. Sever neurologic disease 11. Grade2 or more neuropathy 12. HIV infection

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
progression free survival, response rate, disease control rate, duration of response, toxicity	—

Countries

Japan

Contacts

Public Contactshitara kohei

Aichi Cancer Center Hospital Department of Clinical Oncology

kouheis0824@yahoo.co.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026